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Head Injury Retrieval Trial

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ClinicalTrials.gov Identifier: NCT00112398
Recruitment Status : Terminated (Inadequate recruitment rate combined with a high rate of patients dropping in to the treatment group from standard care)
First Posted : June 3, 2005
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
NSW Motor Accident Authority
Information provided by (Responsible Party):
Alan Garner, CareFlight

Brief Summary:
The study hypothesis is that advanced interventions as provided by a physician at an accident scene will decrease the death rate and the rate of severe disability in survivors of severe head injury. Extended interventions by advanced level prehospital providers may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.

Condition or disease Intervention/treatment
Head Injuries, Closed Procedure: Extended interventions by advanced level prehospital providers

Detailed Description:
A randomised, controlled trial examining prehospital management of persons with severe blunt head injury, in the Sydney region. Treatments examined will be the current system consisting principally of paramedic management (standard care) compared with management by a retrieval team lead by a consultant anaesthetist, emergency physician or intensive care specialist. Patients for inclusion in the study will be identified by a paramedic screening all "000" calls to the ambulance service and identifying persons likely to have severe head injury. The principal outcome measure will be their degree of disability measured at 6 months post injury.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Controlled Trial of Physician Prehospital Management of Severe Blunt Head Injury
Study Start Date : May 2005
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard (paramedic) prehospital care Procedure: Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.
Experimental: Physician prehospital care Procedure: Extended interventions by advanced level prehospital providers
may include rapid sequence intubation (RSI) airway management, blood transfusions, surgical procedures, etc.



Primary Outcome Measures :
  1. Glasgow Outcome Scale Score [ Time Frame: Six months post injury ]

Secondary Outcome Measures :
  1. Length of hospital and intensive care unit stays [ Time Frame: At hospital discharge ]
  2. 30 day survival and survival to discharge from the acute care hospital [ Time Frame: At hospital discharge and 30 days ]
  3. Extended Glasgow Outcome Scale Score [ Time Frame: Six months post injury ]
  4. Disability Rating scale [ Time Frame: Six months post injury ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Glasgow Coma Scale score of 3 to 8 due to blunt trauma as measured at the accident scene by the first prehospital team to arrive at the site.

Exclusion Criteria:

  • Penetrating trauma
  • Age less than 16 years
  • No more than 5 casualties at the scene

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112398


Locations
Australia, New South Wales
CareFlight, PO Box 159
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
CareFlight
NSW Motor Accident Authority
Investigators
Principal Investigator: Alan A Garner, FACEM CareFlight

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan Garner, Medical Director, CareFlight
ClinicalTrials.gov Identifier: NCT00112398     History of Changes
Other Study ID Numbers: HIRT1
First Posted: June 3, 2005    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Alan Garner, CareFlight:
Head injuries
Prehospital
Advanced Interventions

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Head Injuries, Closed
Trauma, Nervous System
Nervous System Diseases
Wounds, Nonpenetrating